Blood GlucoseABWENCT06497972
Blood Glucose Response of Novel Wild Rice Enhanced Food Products (Trial 1)
A study testing Brown rice cake and Wild rice (25%) and brown rice (75%) cake in people with Blood Glucose, run by Dylan MacKay at 1 site in Canada.
Trial summary
The goal of this acute double-blind cross over trial is to test the effects of a wild rice cake product compared to products currently on the market on glycaemic control. The main questions it aims to answer are: 1. What is the effect compared to products currently on the market on glycaemic control? 2. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Brown rice cake and Wild rice (25%) and brown rice (75%) cake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jul 2024to 18 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial
- Male or female between 18-50 years old
- BMI range in between 18.9-29.9 kg/m2
- Fasting glucose <5.6 mmol/L
- Usually eat breakfast
- Participant must receive at least two doses of COVID-19 vaccine that have been recognized by Winnipeg Regional Health Authorities.
- In the Investigator's opinion is able and willing to comply with all trial requirements
Who cannot join
- Fasting glucose ≥ 5.6 mmol/L or <3.5 mmol/L
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Participants who indicate that they could not finish study treatments within 10 minutes
- Use of medication or supplements that may influence carbohydrate metabolism, including, not limit to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of screening visit
- History of disordered eating, AIDS, hepatitis, a history of clinically important endocrine (including Type I and Type II diabetes mellitus), cardiovascular (including but not limit to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders
- Intolerance or allergic reaction to rice
Show all 13Show fewer
- Existing restrictive dietary habits (such a vegan, low carbohydrate/keto) Date and version No: December 12 , 2022, Version 2 Page 7 of 15
- History of hypertension
- History of cancer within the last two years (except for non-melanoma skin cancer)
- Recent history (within 12 month of screening) or current consumption of >14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)
- Body weight change over 3.5kg for the past 3 months
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks
- Had significant physical trauma or major surgery in the past 3 month or had trauma or major surgery in the past 3 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Chronic Disease Innovation Centre, Seven Oaks Hospital
Winnipeg, Manitoba, R2V 3M3
About this study
Official title: Assessing the Blood Glucose Response of Novel Wild Rice Enhanced Food Products (ABWE) Study
The goal of this acute double-blind cross over trial is to test the effects of a wild rice cake product compared to products currently on the market on glycaemic control. The main questions it aims to answer are:
- What is the effect compared to products currently on the market on glycaemic control?
- Is the wild rice product palatable?
Participants will:
- consent to attend 4 study visits being 2.5 hours each
- come to each visit fasted for at least 10-12 hours.
- complete a Motivation to Eat VAS following each blood measure
Read the detailed description
This trial will be an acute double-blind cross-over trial and will investigate 2 types of rice cake products tested against a white bread control. This is the first of the two trials and will be assessing a wild rice cake and a brown rice cake against a control of white bread.
Participants will fast and arrive at the RCFTR between 7:00 and 11:00 am on the session day. They will be provided either of the study treatment based on randomization sequence. Baseline blood glucose (0 min) will be measured twice via finger stick blood sample right before their first bite of the study product, and at 15, 30, 45, 60, 90 and 120 mins after baseline in duplicate. The timer will be started when they take their first bite. VAS will be completed following consumption of the treatments to measure palatability.
The primary objective is to test the effects of a wild rice cake compared to products currently on the market by evaluating factors that influence glycemic response to wild rice in humans, performed via the finger stick blood glucose that will be measured throughout each session as outlined above.
- Conditions
- Blood Glucose
- Being tested
- White bread (control, 32 grams, 14.4 grams of carbohydrate), Brown rice cake, Wild rice (25%) and brown rice (75%) cake, White bread (control, 66 grams, 31 grams of carbohydrate)
- Keywords
- glycemic response, glycemic control, rice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White bread (control, 32 grams, 14.4 grams of carbohydrate)Other
32 grams of white bread, providing 14.4 grams of carbohydrate, which was incorrectly dosed and matched only half the carbohydrate in the rice cakes.
Brown rice cakeOther
A 40g rice cake made of 100% brown rice (providing 31 grams of carbohydrate)
Wild rice (25%) and brown rice (75%) cakeOther
A 40g rice cake made of a blend of 25% wild rice and 75% brown rice (providing 31 grams of carbohydrate)
White bread (control, 66 grams, 31 grams of carbohydrate)Other
66 grams of white bread, providing 31 grams of carbohydrate, this arm was added after the mistake in the first control dosing was discovered, so this arm was not randomized and was completed after the first three.
| Study group | Role | What they receive |
|---|---|---|
| Consumption of the control white bread product (32 grams, 14.4 grams of carbohydrate) | Active comparator | Not described Receives: Other: White bread (control, 32 grams, 14.4 grams of carbohydrate) |
| Consumption of brown rice cake 40 grams (31 grams of carbohydrate) | Experimental | Not described Receives: Other: Brown rice cake |
| Consumption of wild rice brown rice blend cake 40 grams (31 grams of carbohydrate) | Experimental | Not described Receives: Other: Wild rice (25%) and brown rice (75%) cake |
| Consumption of the control white bread product (66 grams, 31 grams of carbohydrate) | Active comparator | This arm was conducted after the first three arms in a non-randomized add on session as we identified an issue with the amount of carbohydrate in out comparator being half of what it was supposed to be. This arm provided 66 grams of white bread control product and there will be a minimum of three days separating each visit. Receives: Other: White bread (control, 66 grams, 31 grams of carbohydrate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of different wild rice products compared to products currently on the market on glycaemic control.
Finger stick blood glucose will be measured throughout each session.
Measured: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes after the first bite of treatment.
Secondary outcomes (1)
To measure the palatability of the wild rice products following consumption.
Visual Analogue Scale (VAS).
Measured: VAS measuring palatability will be completed immediately after the consumption of the treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start5 Jul 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is Trial 1 of a project that will consist of 2 acute double-blind cross-over trials. The trials will follow the same study design but investigate 2 types of wild rice products. The wild rice products will be provided by the Myera group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dylan MacKay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dylan MacKay, University of Manitoba
- Investigators
- Dylan MacKay, PHD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497972
- Sponsor's protocol ID
- HS25756 (B2022:104)
- Acronym
- ABWE
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Blood Glucose Response of Novel Wild Rice Enhanced Food Products (ABWE) Study
- ClinicalTrials.gov ID
- NCT06497972
- Acronym / sponsor ID
- ABWE / HS25756 (B2022:104)
- Conditions
- Blood Glucose
- Keywords
- glycemic response, glycemic control, rice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dylan MacKayUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this acute double-blind cross over trial is to test the effects of a wild rice cake product compared to products currently on the market on glycaemic control. The main questions it aims to answer are:
- What is the effect compared to products currently on the market on glycaemic control?
- Is the wild rice product palatable?
Participants will:
- consent to attend 4 study visits being 2.5 hours each
- come to each visit fasted for at least 10-12 hours.
- complete a Motivation to Eat VAS following each blood measure
Detailed description
This trial will be an acute double-blind cross-over trial and will investigate 2 types of rice cake products tested against a white bread control. This is the first of the two trials and will be assessing a wild rice cake and a brown rice cake against a control of white bread.
Participants will fast and arrive at the RCFTR between 7:00 and 11:00 am on the session day. They will be provided either of the study treatment based on randomization sequence. Baseline blood glucose (0 min) will be measured twice via finger stick blood sample right before their first bite of the study product, and at 15, 30, 45, 60, 90 and 120 mins after baseline in duplicate. The timer will be started when they take their first bite. VAS will be completed following consumption of the treatments to measure palatability.
The primary objective is to test the effects of a wild rice cake compared to products currently on the market by evaluating factors that influence glycemic response to wild rice in humans, performed via the finger stick blood glucose that will be measured throughout each session as outlined above.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is Trial 1 of a project that will consist of 2 acute double-blind cross-over trials. The trials will follow the same study design but investigate 2 types of wild rice products. The wild rice products will be provided by the Myera group.
| Arm | Type | Receives |
|---|---|---|
| Consumption of the control white bread product (32 grams, 14.4 grams of carbohydrate) | Active comparator | Other: White bread (control, 32 grams, 14.4 grams of carbohydrate) |
| Consumption of brown rice cake 40 grams (31 grams of carbohydrate) | Experimental | Other: Brown rice cake |
| Consumption of wild rice brown rice blend cake 40 grams (31 grams of carbohydrate) | Experimental | Other: Wild rice (25%) and brown rice (75%) cake |
| Consumption of the control white bread product (66 grams, 31 grams of carbohydrate) | Active comparator | Other: White bread (control, 66 grams, 31 grams of carbohydrate)This arm was conducted after the first three arms in a non-randomized add on session as we identified an issue with the amount of carbohydrate in out comparator being half of what it was supposed to be. This arm provided 66 grams of white bread control product and there will be a minimum of three days separating each visit. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant is willing and able to give informed consent for participation in the trial
- Male or female between 18-50 years old
- BMI range in between 18.9-29.9 kg/m2
- Fasting glucose <5.6 mmol/L
- Usually eat breakfast
Key exclusion criteria (13 listed)
- Fasting glucose ≥ 5.6 mmol/L or <3.5 mmol/L
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Participants who indicate that they could not finish study treatments within 10 minutes
- Use of medication or supplements that may influence carbohydrate metabolism, including, not limit to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of screening visit
- History of disordered eating, AIDS, hepatitis, a history of clinically important endocrine (including Type I and Type II diabetes mellitus), cardiovascular (including but not limit to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White bread (control, 32 grams, 14.4 grams of carbohydrate)32 grams of white bread, providing 14.4 grams of carbohydrate, which was incorrectly dosed and matched only half the carbohydrate in the rice cakes. | Other | Consumption of the control white bread product (32 grams, 14.4 grams of carbohydrate) |
| Brown rice cakeA 40g rice cake made of 100% brown rice (providing 31 grams of carbohydrate) | Other | Consumption of brown rice cake 40 grams (31 grams of carbohydrate) |
| Wild rice (25%) and brown rice (75%) cakeA 40g rice cake made of a blend of 25% wild rice and 75% brown rice (providing 31 grams of carbohydrate) | Other | Consumption of wild rice brown rice blend cake 40 grams (31 grams of carbohydrate) |
| White bread (control, 66 grams, 31 grams of carbohydrate)66 grams of white bread, providing 31 grams of carbohydrate, this arm was added after the mistake in the first control dosing was discovered, so this arm was not randomized and was completed after the first three. | Other | Consumption of the control white bread product (66 grams, 31 grams of carbohydrate) |
Primary outcome
The effects of different wild rice products compared to products currently on the market on glycaemic control.
Time frame: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes after the first bite of treatment.
Finger stick blood glucose will be measured throughout each session.
1 secondary outcome
To measure the palatability of the wild rice products following consumption.
Time frame: VAS measuring palatability will be completed immediately after the consumption of the treatments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan MacKay, PHD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brown rice cake and Wild rice (25%) and brown rice (75%) cake in people with Blood Glucose, run by Dylan MacKay at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of different wild rice products compared to products currently on the market on glycaemic control. (time frame: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes after the first bite of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.